FDA Device recall Z-0734-2020
Lamicel 20PK 5MM INTL
- FDA Device
- Class II
- ongoing
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class II recall of Lamicel 20PK 5MM INTL by Medtronic Xomed, citing routine sterilization dose does not meet the required Sterility Assurance Level.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0734-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-11-13 |
| Published | 2020-01-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Xomed |
| Distribution | n/a |
Product
Lamicel 20PK 5MM INTL
Reason
Routine sterilization dose does not meet the required Sterility Assurance Level.
Identifiers
| code_info | UDI: 20885074749055; SPONGE 2203-501EX LAMICEL 20PK 5MM INTL; 2203-501EX; Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0734-2020%22
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